Letrozol Combix 2.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Letrozol Combix 2.5 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

1. What Letrozol Combix is and what it is used for
2. What you need to know before taking Letrozol Combix
3. How to take Letrozol Combix
4. Possible side effects
5. How to store Letrozol Combix
6. Contents of the pack and other information

1. What Letrozol Combix is and what it is used for

What Letrozol Combix is and how it works

Letrozol Combix contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are female sex hormones. Letrozol Combix reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and thus can inhibit the growth of breast cancers that require estrogen to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What Letrozol Combix is used for

Letrozol Combix is used to treat breast cancer in women who have undergone menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Combix is also used to prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol Combix works or why you have been prescribed this medicine, consult your doctor.

2. What you need to know before starting to take Letrozol Combix

Carefully follow all instructions given by your doctor. These may differ from the general information contained in this leaflet.

Do not take Letrozol Combix

• if you are allergic to letrozol or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, that is, have not yet reached menopause,
• if you are pregnant,
• if you are breastfeeding.

If any of these cases applies to you, do not take this medicine and inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Letrozol Combix

• if you have severe kidney disease,
• if you have severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Monitoring of treatment with Letrozol Combix” in section 3).

If any of these cases applies to you, inform your doctor. Your doctor will take this into account during your treatment with Letrozol Combix.

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over may use this medicine at the same dose as adults.

Taking Letrozol Combix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• You should only take Letrozol Combix if you have passed the menopausal stage. However, your doctor should discuss with you the need to use effective contraception, as you could still become pregnant during treatment with Letrozol Combix.

• You must not take Letrozol Combix if you are pregnant or breastfeeding, as it may harm your baby.

Driving and use of machines

If you feel dizzy, tired, drowsy, or unwell, do not drive or operate tools or machinery until you feel well again.

Letrozol Combix contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Use in athletes

This medicine contains letrozol, which may result in a positive doping test.

Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of tendon pain or inflammation, rest the affected area and contact your doctor immediately.

3. How to take Letrozol Combix

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one Letrozol Combix tablet once daily. Taking Letrozol Combix at the same time each day will help you remember when to take the tablet.

The tablet may be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrozol Combix

Continue taking Letrozol Combix every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozol Combix, consult your doctor.

Monitoring of treatment with Letrozol Combix

You should only take this medicine under strict medical supervision. Your doctor will periodically monitor your condition to ensure the treatment is having the desired effect.

Letrozol Combix may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to perform bone density measurements (a way of monitoring osteoporosis) before, during, and after treatment.

If you take more Letrozol Combix than you should

If you have taken too many Letrozol Combix tablets, or if someone else has accidentally taken them, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment. You can also call the Toxicology Information Service at telephone number: 915620420, stating the medicine and the amount taken.

If you forget to take Letrozol Combix

• If it is almost time for your next dose (e.g., only 2 or 3 hours left), do not take the missed dose and take the next dose at your usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the following dose at your normal time.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Letrozol Combix

Do not stop taking Letrozol Combix unless your doctor tells you to. See also the section "How long to take Letrozol Combix".

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Most of the adverse effects are mild to moderate and usually disappear after a few days or weeks of treatment.

Some of these adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to estrogen deficiency.

Do not be alarmed by this list of possible adverse effects. You may not experience any of them.

Some adverse effects may be serious:

Rare or uncommon adverse effects (i.e., may affect 1 to 100 in every 10,000 patients):

• Weakness, paralysis, or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, crushing chest pain (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Swelling and redness in a vein that is extremely tender and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (due to low white blood cell count).
• Severe, persistent blurred vision.
• Tendon rupture (connective tissue linking muscles to bones).

If you experience any of the above conditions, inform your doctor immediately.

You should also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Combix:

• Swelling, mainly in the face and throat (signs of an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common. These adverse effects may affect more than 10 in every 100 patients.

• Hot flushes.
• Elevated cholesterol levels (hypercholesterolemia).
• Fatigue.
• Increased sweating.
• Bone and joint pain (arthralgia).

If any of these effects severely affect you, consult your doctor.

Some adverse effects are common. These adverse effects may affect 1 to 10 in every 100 patients.

• Skin rash.
• Headache.
• Dizziness.
• General malaise.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Bone thinning or loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Combix treatment” in section 3).
• Swelling of arms, hands, feet, or ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• Increased blood pressure (hypertension).
• Abdominal pain.
• Dry skin.
• Vaginal bleeding.
• Palpitations, rapid heart rate.
• Joint stiffness (arthritis).
• Chest pain.

If any of these severely affect you, inform your doctor.

Some adverse effects are uncommon. These adverse effects may affect 1 to 10 in every 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Sensory disturbances, especially related to touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria).
• Vaginal dryness or discharge.
• Breast pain.
• Fever.
• Thirst, taste disturbances, dry mouth.
• Dryness of mucous membranes.
• Weight loss.
• Urinary tract infection, increased frequency of urination.
• Cough.
• Increased enzyme levels.
• Yellowish discoloration of the skin and eyes.
• Elevated blood levels of bilirubin (a byproduct of red blood cell breakdown).
• Tendinitis or inflammation of a tendon (connective tissue linking muscles to bones).

If any of these severely affect you, inform your doctor.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Combix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Keep in the original packaging to protect from moisture.

Do not use any pack that is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Return unused packs and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol Combix

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are: lactose monohydrate (lactose), microcrystalline cellulose (E460i), sodium carboxymethyl starch from potato (potato starch), maize starch, anhydrous colloidal silica (E551), magnesium stearate (E470b). The coating consists of hypromellose (E464), titanium dioxide (E171) and macrogol (E1521).

Appearance of Letrozol Combix and contents of the pack

• Letrozol Combix is presented as film-coated tablets. The tablets are white, round, biconvex, marked with "ZF5" on one side and smooth on the other.
• Each blister pack contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Date of latest review of this leaflet: August 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.